BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19901228 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18921
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931559 - MDR 3003442380-2024-18921 - DEVICE 4 OF 12

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN ADHESIVE EVENT WHERE 12 INFUSION SETS FELL OFF BETWEEN (B)(6)2024 DURING USE.THE INFUSION SET HAS BEEN USED FOR 1-2 DAYS. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399767 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6004794 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female